Phase 1 Stomach Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a solid tumour cancer that has spread or cannot be surgically removed, confirmed by laboratory testing of tumour tissue or cells, and who have run out of standard treatment options (Parts A and B).
• In Part A (dose escalation), the cancer must be one of these specific types: colorectal cancer, stomach cancer, cancer at the junction of the stomach and oesophagus, non-small cell lung cancer, or pancreatic ductal adenocarcinoma.
• In Part C (dose expansion), people with colorectal cancer who have received no more than 2 prior chemotherapy treatments for advanced disease and whose cancer has grown or who could not tolerate their last treatment.
• In Part C, people with pancreatic ductal adenocarcinoma who have visible tumour spots on CT or MRI scans, and who have received no more than 1 prior chemotherapy treatment for advanced disease and whose cancer has grown or who could not tolerate that treatment.
• In Part C, people with stomach cancer or stomach-oesophageal junction cancer who have previously received platinum- and fluoropyrimidine-based chemotherapy.
• In Part C, people with non-small cell lung cancer who have previously received platinum-based chemotherapy, and also a PD-1/PD-L1 immunotherapy drug if that was appropriate under local treatment guidelines, as well as any approved targeted therapies if relevant genetic changes were found in their tumour.
• In Part C, people with small cell lung cancer at an advanced stage who have received platinum-based chemotherapy and no more than 3 prior lines of treatment, and also a PD-1/PD-L1 immunotherapy drug if that was appropriate under local treatment guidelines.
• In Parts D and E (combination therapy with bevacizumab), people with colorectal cancer confirmed by tissue testing that has spread or cannot be removed, who have had no more than 2 prior chemotherapy treatments for advanced disease and whose cancer has progressed or who could not tolerate their last treatment.
• In Parts D and E (specific combination therapy groups), people with colorectal cancer who have never previously received a TOPO1 inhibitor drug such as irinotecan, with different requirements depending on whether they are in a first-line or second-line treatment group (confirm details with trial site).
• In Part E, people with metastatic pancreatic ductal adenocarcinoma with measurable tumour spots on CT or MRI scans who have received prior chemotherapy (second-line group), or who have not previously been treated for metastatic disease — with an exception for people who had adjuvant or pre-surgery chemotherapy and whose cancer came back more than 12 months after finishing that treatment (first-line group).
• People who have a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity.
• People who have at least one tumour that can be measured on imaging scans at the start of the trial.
• For some parts of the trial (Parts B, C, and E), people who have a tumour that can be safely biopsied and who agree to provide biopsy samples and/or stored tissue samples.

Who may not be able to join:

• People who have previously received any treatment specifically targeting the CEACAM5 protein.
• People who have previously received a TOPO1-targeting antibody-drug conjugate, such as trastuzumab deruxtecan (Enhertu) or sacituzumab govitecan (Trodelvy).
• People who have had another cancer within the past 3 years before starting the trial, or who still show signs of a previously diagnosed cancer.
• People who currently have active cancer involvement in the brain or the lining of the brain or spinal cord — although people with a past history of this may still be considered if the brain disease has been treated, they are medically stable, have not needed steroid treatment for brain-related symptoms for at least 2 weeks before enrolment, and have no ongoing related side effects.
• People with a known allergy or serious reaction to bevacizumab or any of its ingredients (relevant to Parts D and E).
• People with a known allergy to products made from Chinese Hamster Ovary cells, or to other laboratory-made human or humanised antibody treatments (relevant to Parts D and E).
• People with a serious wound, ulcer, or bone fracture that has not been healing (relevant to Parts D and E).
• People who have had a deep vein blood clot within 4 weeks before enrolling in the trial (relevant to Parts D and E).
• People with a known blood clotting disorder that increases the risk of bleeding (relevant to Parts D and E).
• People who have previously experienced a life-threatening side effect related to VEGF-targeting treatments (relevant to Parts D and E).

Important: Always verify eligibility with the trial site directly before applying.